Canadian Pegvisomant Compassionate Study In Acromegalic Patients

Pfizer

Status and phase: Completed; Phase 4

Conditions: Acromegaly

Treatments: Procedure: Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT; Procedure: Medical History, demographics; Drug: Pegvisomant treatment; Procedure: MRI; Procedure: Sign and symptoms: questionnaire

Study type: Interventional

Funder types: Industry

Identifiers

NCT00151437

A6291017

Details and patient eligibility

About

The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the safety and tolerability of SOMAVERT.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies

Exclusion criteria

• ALT/AST>3 times the ULN or have hepatic disease
• have severe visual field loss, cranial nerve palsies or intracranial HTN that requires surgery to decompress the tumor
• unwilling to self-administer the medication.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)